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NCT07795814PHASE2Recruiting

A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)

Edgewise Therapeutics, Inc.

Start Date

8/25/2026

Completion Date

12/1/2027

Summary

This is a Phase 2 placebo-controlled study to evaluate the safety and tolerability of different doses of EDG-15400 in adults with heart failure with preserved ejection fraction (HFpEF).

Eligibility Criteria

Age Range: 30 years to 84 years

Inclusion Criteria: * Males and nonpregnant females, ages ≥30 to \<85 years of age at screening * Body weight ≥ 45 kg, BMI \< 40 * LVEF ≥ 50% * Diagnosed with Heart Failure per American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines for the Management of Heart Failure * New York Heart Association (NYHA) functional class II or III * If receiving Guideline-directed Medical Therapy, must be on stable doses * Participants receiving a GLP-1 agonist prior to Screening must have no anticipated plans to change dose during the study Exclusion Criteria: * Known diagnosis of hypertrophic cardiomyopathy (HCM) * Known or suspected infiltrative or storage disorder (e.g., Noonan syndrome, Fabry disease, amyloidosis) * Moderate or greater interstitial lung disease (ILD) or ILD requiring chronic supplemental O2 therapy * Severe or greater chronic obstructive pulmonary disease (COPD) or COPD requiring chronic supplementary O2 therapy * Hospitalization for any reason within 60 days prior to Screening * History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the Investigator or the Medical Monitor, would be an alternative explanation for heart failure symptoms (e.g., significant lung disease, anemia) and/or would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion

Interventions

DRUG

EDG-15400 25 mg

DRUG

Placebo to match EDG-15400 25 mg or 50 mg

DRUG

EDG-15400 50 mg

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Conditions

Heart Failure With Preserved Ejection Fraction

Locations

Local Institution - 1

Birmingham, Alabama 35211

United States

Local Institution - 25

Little Rock, Arkansas 72205

United States

Local Institution - 2

Beverly Hills, California 90211

United States

Local Institution - 3

San Diego, California 92037

United States

Local Institution - 4

Vista, California 92081

United States

Local Institution - 24

Gainesville, Florida 32608

United States

Local Institution - 5

Peoria, Illinois 61636

United States

Local Institution - 26

Fort Wayne, Indiana 46804

United States

Local Institution - 6

Indianapolis, Indiana 46260

United States

Local Institution - 7

Houma, Louisiana 70360

United States

Local Institution - 8

Baltimore, Maryland 21287

United States

Local Institution - 9

Ypsilanti, Michigan 48197

United States

Local Institution - 28

Minneapolis, Minnesota 55407

United States

Local Institution - 10

Jackson, Mississippi 39216

United States

Local Institution - 11

Kansas City, Missouri 64131

United States

Local Institution - 12

St Louis, Missouri 63130

United States

Local Institution - 13

New York, New York 10019

United States

Local Institution - 14

Greensboro, North Carolina 27401

United States

Local Institution - 15

Cincinnati, Ohio 45219

United States

Local Institution - 27

Tulsa, Oklahoma 74104

United States

Local Institution - 16

Mechanicsburg, Pennsylvania 17050

United States

Local Institution - 17

Charleston, South Carolina 29425

United States

Local Institution - 18

Dallas, Texas 75390

United States

Local Institution - 19

Houston, Texas 77030

United States

Local Institution - 20

Houston, Texas 77030

United States

Local Institution - 21

Houston, Texas 77030

United States

Local Institution - 22

Charlottesville, Virginia 22908

United States

Local Institution - 23

Seattle, Washington 98101

United States